Determining the hearing changes of patients with a history of radical mastoidectomy who undergo surgery to replace the stapes bone plate with fat.
Design
Clinical trial with a single intervention group, non-randomized, phase 2 on 35 patients.
Settings and conduct
Patients who have a previous history of mastoidectomy and have referred to the ENT clinic of Loqman Hospital in Tehran are evaluated by audiometry test. Then, if all the inclusion criteria are met, the epithelium and foot plate of healthy stapes bone will be removed in the area of the oval valve, and the valve will be covered with a fat graft removed from the lobule, and Gelfoam will be placed on it. One day after the surgery, diapason tests will be done to make sure of the carrier. Then, the patient is subjected to an audiometry test at intervals of one month and six months after the surgery, and the hearing changes are compared with before the surgery.
Participants/Inclusion and exclusion criteria
Patients older than 18 years old and with a history of previous radical mastoidectomy who have at least 6 months of dry cavity, and in the audiometric test, bone conduction is less than 35, air conduction is more than 50, the affected ear be non-serviceable and the opposite ear be serviceable, enrolled in the study. Patients with evidence of active ear infection are not included in the study.
Intervention groups
The healthy stapes bone epithelium and footplate in the oval valve area will be removed and the valve will be covered with a fat graft removed from the lobule.
Main outcome variables
Hearing changes based on standard audiometric test parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220803055606N2
Registration date:2022-10-15, 1401/07/23
Registration timing:registered_while_recruiting
Last update:2022-10-15, 1401/07/23
Update count:0
Registration date
2022-10-15, 1401/07/23
Registrant information
Name
alireza moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6522 4135
Email address
alirezamoradi_md@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Changes in the air Conduction due to replacement of footplate of stapes bone with fat in patients with radical mastoidectomy
Public title
Changes in the air Conduction due to replacement of footplate of stapes bone with fat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
History of radical mastoidectomy
Had a dry cavity for at least 6 months
The amount of air conduction is more than 50
The amount of bone conduction is less than 35
The affected ear is non-serviceable
The opposite ear is serviceable
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1333635445
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.SBMU.MSP.REC.1400.159
Health conditions studied
1
Description of health condition studied
radical mastoidectomy
ICD-10 code
H95.1
ICD-10 code description
Other disorders of ear and mastoid process following mastoidectomy
Primary outcomes
1
Description
Audiometric parameters
Timepoint
Before, one month and six months after the operation
Method of measurement
Standard audiometric test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Epithelium and foot plate of the healthy stapes bone in the area of the oval valve will be removed and the valve will be covered with fat taken from the lobule and gelfoam will be placed on it.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Educational Hospital
Full name of responsible person
Dr. Farhad Mokhtari Nejad
Street address
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Moradi
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Navab safavi
City
Shahriyar
Province
Tehran
Postal code
1333635445
Phone
+98 21 6522 4135
Fax
Email
alirezamoradi_MD@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Farhad Mokhtarinejad
Position
Asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mokhtarinejad.f@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Moradi
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Navab safavi
City
Shahriyar
Province
Tehran
Postal code
1333635445
Phone
+98 21 6522 4135
Fax
Email
alirezamoradi_MD@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The clinical report and study protocol will be published in the form of a scientific article. However, no decision has been made yet regarding the publication of the data file of the participants and the analysis map. However, it can only be provided to related individuals or organizations in special cases
When the data will become available and for how long
The access period starts from 2022
To whom data/document is available
Academic researchers and healthcare officials
Under which criteria data/document could be used
The IPD file and the study protocol can be used upon request by relevant organizations and decision-makers in the field of health in order to check its accuracy and/or to use it in the design of subsequent studies by mentioning the primary source.
From where data/document is obtainable
Ear Research Center of Luqman Hakim Hospital
What processes are involved for a request to access data/document
Written request to the scientific officer of the study